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BAF-FRontier-1

LY4152199 for B-cell Malignancies After Prior Treatment

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What is being tested

LY4152199 - IV

+ LY4152199 - SC
Drug
Who is being recruted

Leukemia, Lymphocytic, Chronic, B-Cell
+7

+ Lymphoma, B-cell Marginal Zone
+ Lymphoma, Non-Hodgkin
Over 18 Years
+31 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2025

See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2025Actual date on which the first participant was enrolled.

This study is focused on evaluating a new medication called LY4152199 for adults who have previously been treated for B-cell lymphoma or leukemia. These are types of blood cancers that affect the B-cells, a kind of white blood cell. The goal is to assess how safe the drug is and how well it works in treating these cancers, especially for those who haven't found success with other treatments. Understanding the effects of LY4152199 could offer new hope and treatment options for patients facing these challenging conditions. The study involves two main parts. Initially, participants will help determine the best dose of LY4152199, ensuring it is both safe and potentially effective. In this phase, researchers will monitor participants closely for any side effects. Once the optimal dose is identified, the second part of the study will evaluate how well this dose works in treating specific types of B-cell cancers and leukemia. Participants will receive the drug and undergo regular health checks to see how their cancer responds to the treatment, providing essential data on its potential benefits and risks.

Official TitleBAF-FRontier-1, A First-in-Human, Phase 1a/1b Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies 
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
295 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-cell Marginal Zone
Lymphoma, Non-Hodgkin
B-cell Lymphoma
Waldenstrom Macroglobulinemia
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Burkitt Lymphoma
Lymphoma, Follicular
Leukemia, B-Cell
Criteria
16 inclusion criteria required to participate
Participants with select tumor types must have measurable or assessable disease as defined below: * Participants with lymphoma and Richter transformation (RT) must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement, elevated immunoglobulin M (IgM) levels and/or lymphocytosis. * Participants with Waldenstrom macroglobulinemia (WM) must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than (\>)2 times (×) upper limit of normal (ULN) based on local laboratory testing. * Participants with chronic lymphocytic leukemia (CLL) must have assessable disease in blood or bone marrow by flow cytometry or immunohistochemistry.
Transplant eligibility or ineligibility may be determined by the Investigator, who may consider factors such as age, overall fitness, comorbidities, and prior treatment history of the participant.
Must have histologically confirmed diagnosis of relapsed/refractory B-cell malignancies as defined below per specific cohort.
Must have histologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed.

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15 exclusion criteria prevent from participating
Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Known hypersensitivity to any component or excipient of LY4152199.
Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.
Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody). This exclusion criterion does not apply to participants seeking retreatment.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Escalating doses of LY4152199 administered intravenously (IV) or subcutaneously (SC)
Group II
Experimental
Two or more doses of LY4152199 (evaluated during dose escalation) administered SC
Group III
Experimental
LY4152199 administered SC
Study Objectives
Primary Objectives

Assessed by the Investigator per disease-specific response criteria as appropriate or death due to any cause, whichever occurs first
Secondary Objectives

Assessed by the Investigator per disease-specific response criteria as appropriate or death due to any cause, whichever occurs first

Time between the date of first documented response (CR or PR) to the date of first disease progression or death due to any cause, whichever occurs first

Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented response (CR or PR)

Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented disease progression or death due to any cause, whichever occurs first

Percentage of efficacy-evaluable participants who achieved a BOR of CR, PR, or stable disease

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 45 locations
Suspended
City of HopeDuarte, United StatesSee the location
Suspended
University of Colorado Denver - School of Medicine - Anschutz Medical CampusAurora, United States
Suspended
Colorado Blood Cancer InstituteDenver, United States
Suspended
Yale University School of Medicine - Yale Cancer CenterNew Haven, United States
Recruiting soon45 Study Centers